Synthes Zero-P StarDrive Screwdriver Shaft, T8… recallZ-1348-2009 · Synthes Spine · initiated Feb 10, 2009
Terminated All recalls posted in June 2009
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Synthes Spine or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Tip breakage, due to inadequate instructions for use. The Technique Guide provided incorrect information related to use of the Torque Limiting Attachment during screw insertion and final tightening.
FDA root cause category: Labeling design
What the company is doing
All affected Synthes Spine Sales Consultants were notified of the Labeling Correction via email on February 10, 2009. They were instructed to review changes with their surgeons. They were supplied with an electronic version of the corrected Technique Guide on March 11, 2009. All affected Synthes Sales Consultants and Customers were notified of this labeling change via distribution of the updated Technique Guide and a notification letter. This packet was sent via USPS certified mail on March 26, 2009. To ensure a broad and accurate distribution of notification, affected consultants and customers are defined as having been shipped Zero-P 3.0 mm Titanium Cervical Spine Locking Screws. These devices are used only with the Zero-P system.
Recall details
- Recall number
- Z-1348-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 10, 2009
- Posted by the FDA
- Jun 10, 2009
- Recalling firm
- Synthes Spine
- Quantity
- 1766 units
- Product code
- ODP
- FDA submissions
- K072981
- Distribution
- Distributed Nationwide and Canada.
Product description
Synthes Zero-P StarDrive Screwdriver Shaft, T8, self-retaining, quick coupling, for use in spinal fusion surgery. Catalog # 03.617.902 Technique Guide.
Code information (models, lots, serial numbers)
Catalog # 03.617.902 - All lots
Other devices under the same FDA submission
6 devices cleared under K072981 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- NA 04.617.816Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical10 reports
- NA 04.617.814Synthes GmbH · Intervertebral fusion device with integrated fixation, cervical9 reports
- Zero-P 04.617.128SSynthes GmbH · Intervertebral fusion device with integrated fixation, cervical4 reports
- Zero-P 04.617.127SSynthes GmbH · Intervertebral fusion device with integrated fixation, cervical2 reports
- Zero-P 04.617.125SSynthes GmbH · Intervertebral fusion device with integrated fixation, cervical1 report
- Zero-P 04.617.136SSynthes GmbH · Intervertebral fusion device with integrated fixation, cervical1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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